Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs
BLOCKING Act of 2019
USA116th CongressHR-938| House
| Updated: 5/2/2019
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs